Effective Date on Documents

[tebusse]

All,

Please correct me if I'm wrong - within 21 CFR 820, ISO 13485:2016, and the MDD, I cannot find that having the effective date on a document is required. All that is required is that the document was reviewed and approved, has an identifier (e.g. name, number, revision level, etc.).

Here's my conundrum...

We currently place effective dates on our documents. However, we utilize document management software that appends a page at the end of each document with signature of the reviewers, the document approval date and the publication date. I would think that the publication date can serve as the effective date. Otherwise, we always have to carefully coordinate the effective date on the document and the publication within the software system. Please note, reviewers applying their signatures are in a queue. If someone doesn't approve the document until after the effective date we outline on the document, the process has to start over.

Please advise.

Tonia

 

[Ninja]

A curiosity...
Is there a requirement that the effective date must be after all signatures?

I am not in medical, nor was ever under 21CFR820...but under ISO9001 and TS16949, I had effective dates months in advance of signatures in some cases...

The root of my question is: Are you creating your own problem?

 

[tebusse]

A curiosity...
Is there a requirement that the effective date must be after all signatures?

I am not in medical, nor was ever under 21CFR820...but under ISO9001 and TS16949, I had effective dates months in advance of signatures in some cases...

The root of my question is: Are you creating your own problem?

Ninja,

The way the document management system software works is that a document is routed for review, reviewers approve (e.g. signatures) and then the document is published once all reviewers have approved it. Please note, the publication is not automatic once the final reviewer signs. Document control my manually publish the document within the system.

 

[Ninja]

Understood...but you didn't answer the question...

Is there a requirement that the effective date be after all signatory dates?

Wording it another way...
You have an effective date of November 1, 2018.
You have two signatures: one on 10/25/18, one on 11/25/18...
what is the problem with the effective date being between those two dates?
Where does the "It must be after all signature dates" requirement come from?

 

[tebusse]

For me it's a moot point as our electronic document system doesn't allow signatures to be placed after the document becoming effective.

 

[DEVigil]

Understood...but you didn't answer the question...

Is there a requirement that the effective date be after all signatory dates?

Wording it another way...
You have an effective date of November 1, 2018.
You have two signatures: one on 10/25/18, one on 11/25/18...
what is the problem with the effective date being between those two dates?
Where does the "It must be after all signature dates" requirement come from?

That depends.

ISO 13485:2016 4.2.4 requires that documents shall be reviewed and approved for adequacy prior to issue. Approval should come from someone with access to pertinent background information upon which to base the decision. So, if the signature is of a required approver, the document cannot be effective before it's been approved by them. This is mirrored in the language in 21 CFR 820.40.

However, some organizations have other functions approve documents as well (e.g., it has to pass through a more administrative QC-type review to make sure the format is correct, etc.). If it is an approval that is not related to the content, then you could argue the document was effective when approved by the required approving function.

 

[Ninja]

our electronic document system doesn't allow signatures to be placed after the document becoming effective.

Got it...it is your software imposing the requirement.
In that case, it seems like you need a business system of "forewarned and expected" in order to get around the software imposed restriction.
have everyone notified and in agreement before you release it through the software.

reviewed and approved for adequacy prior to issue.

Don't mean to be semantic or pedantic...but "issue" and "effective as of" are two different things...aren't they?

As said many times, I am not in medical...I understand that words may mean different things in a different field.

 

[DEVigil]

Don't mean to be semantic or pedantic...but "issue" and "effective as of" are two different things...aren't they?

As said many times, I am not in medical...I understand that words may mean different things in a different field.

Yes, but I have trouble envisioning how something could be effective before it was issued, so it is both pedantic and moot.

 

[Ninja]

I have trouble envisioning how something could be effective before it was issued

The document effective before issue...can't happen (-ish).
The process documented is often effective before the document is issued (at least in non-med).
It has to exist before you can document it.

We find a better way to do things...so we start doing them that way immediately...why wouldn't we?
A waiver is written to allow this deviation.
Then the document is updated to reflect the new process tweaks...effective date is the day we started using the new process, which is prior to the document catching up. Thus "Issue date" is often later than "effective date"....hardly moot, but I'll agree on pedantic.

I suppose folks handle the concept of "effective date" differently...I always put it at when the process being documented became effective.

 

[DEVigil]

We find a better way to do things...so we start doing them that way immediately...why wouldn't we?

Because it is not a controlled, documented process if you can just change it willy nilly. Seriously.